Cirtec Medical

Quality Engineer II

Cirtec Medical • $80K — $103K *
Lowell, MA 01852In-Person
Healthcare
Less than 5 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a STEM engineering discipline
  • 2+ years of experience in Quality Engineering
  • Experience in mechanical, tool design, and manufacturing processes, preferably in medical devices
  • Proficient in data analysis and process improvement methodologies
  • Fluent with Microsoft Office and related software tools
  • Strong verbal communication and organizational skills

Responsibilities

  • Monitor and audit the quality of manufactured goods in the medical device industry
  • Support engineering project development and sustained manufacturing as a Quality Engineer
  • Manage validation systems and develop validation master plans
  • Create and maintain Quality Plans and Standard Operating Procedures
  • Conduct statistical analyses, develop protocols, and write validation reports
  • Implement and support installation and operational qualification protocols
  • Lead corrective and preventive action initiatives and investigations

Benefits

  • Support for professional development and training
  • Opportunities for career advancement within the company
  • Flexible work environment promoting work-life balance
  • Involvement in innovative projects in the medical device industry
  • Collaborative team culture with cross-functional interactions
Full Job Description
Description

Position Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Key Responsibilities:

  • Provide Quality Engineering support for engineering project development, or sustained manufacturing.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Conduct validations to ensure robust processing and monitors output to reduce PPM failures.
  • Support Risk Management activities for New Product Development (NPD) programs within our Precision Component Business
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material via NCR's.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.

Must Have:

  • A Bachelor's degree in a STEM engineering discipline
  • 2+ years of experience in Quality Engineering required
  • Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to read, write and speak fluent English.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

Salary Range: $80000-103000 depending on skills and experience

About Cirtec Medical

Cirtec Medical is a medical device company that designs, develops, and manufactures implantable medical devices and components. The company's products are used in a variety of medical applications, including cardiovascular, orthopedic, and neurological procedures. Cirtec Medical was founded in 2014 and is headquartered in Irvine, California.
Learn more about Cirtec Medical
Size
1,000 employees
Industry
Healthcare
Founded
2009
* Ladders Estimates

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